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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006823
Receipt No. R000008068
Scientific Title Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Date of disclosure of the study information 2011/12/03
Last modified on 2011/12/03

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Basic information
Public title Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Acronym Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Scientific Title Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Scientific Title:Acronym Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate efficacy and safety of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatn-based chemoterapy without CV port.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate
Progression free survival
Overall survival
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy
1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD
2)S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks
3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed colorectal cancer.
2) Clinically proven unresectable advanced / metastatic colorectal cancer
3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy)
4) Presence of at least one measurable lesion (according to the RECIST ver.1.1)
5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion
6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
7) Patients unaffected prior therapy
At least 4-6 weeks since prior radiotherapy
At least 4 weeks since prior operation for organ
At least 2 weeks since prior chemotherapy
At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy
8) More than 20 years of age
9) ECOG performance status 0-1
10) Adequate organ function for study treatment
WBC>=3,000mm3, neutrophils>=1,000/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dl
AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
Total bilirubin<=upper limit of normal (ULN)*2
Creatinine<=1.5mg/dl
11) Oral food intake possible
12) Life expectancy must be 3 months or longer after the combination therapy
13) Written informed consen+C120t
Key exclusion criteria 1) History of severe allergy
2) Simultaneous or metachronous double cancers
3) Symptomatic brain metastasis
4) Severe infectious disease
5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice)
6) Paralytic or mechanical bowel obstruction
7) Massive pleural effusion or ascites
8) Wattery diarrhea
9) Patients who is receiving Atazanavir Sulfate or Flucytosine
10) Pregnant or lactating women or women of childbearing potential
11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University Faculty of Medicine
Division name Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
Homepage URL
Email

Sponsor
Institute Fukuoka Tumor Research(FUTURE)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福岡大学医学部消化器外科学

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 03 Day
Last modified on
2011 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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